Professional Empty Capsule Solutions

Yes. Our HPMC vacant capsules are supported by an active Type IV Drug Master File (DMF #31186). This ensures full regulatory transparency and simplifies the filing process for pharmaceutical manufacturers worldwide.

We offer a complete spectrum of sizes to meet various formulation needs, including Size 000, Size 00, Size 0, and Sizes 1 through 5. Each size follows precise technical dimensions, such as 26.1mm for capsules-size000.webp and 23.3mm for capsules-size00.webp, ensuring consistent performance.

Of course. Our capsules are manufactured in strict accordance with ISO 9001:2015 quality standards. They are designed with precision tolerances to ensure a 99.9% filling success rate on NJP series automatic capsule filling machines and other industrial equipment.

Our production site is U.S. FDA Registered and operates under a comprehensive ISO 9001:2015 Quality Management System. These certifications cover the manufacture of gelatin vacant capsules, enteric gelatin hollow capsules, and hydroxypropyl methyl cellulose (HPMC) shells.

Our pharmaceutical grade empty capsules are engineered with a precise "pre-lock" feature. This design prevents premature separation during transit while ensuring smooth opening on automatic machines like the NJP series. Using capsules-size00.webp as an example, the concentricity is controlled within microns to eliminate downtime caused by crushed shells.

Our capsules undergo rigorous moisture balance testing. We strictly control the wall thickness (especially for size 00 and 0 capsules) to ensure that the capsule shells have sufficient structural integrity, preventing stacking or breakage even when filled at a rate of up to 150,000 capsules per hour on a high-speed automatic capsule filling machine.

Weight capacity depends on the powder density ($0.6\text{g/ml}$ to $1.2\text{g/ml}$), but generally:

• Size 000 (26.1mm): Can hold between $800\text{mg}$ and $1600\text{mg}$.

• Size 5 (14.8mm): Ideal for micro-dosing between $60\text{mg}$ and $130\text{mg}$.

• For precise dosing data, please refer to our capsule-size-05.webp and capsules-size000.webp technical spec sheets.

Yes. We provide a Letter of Authorization (LOA) for clients purchasing our HPMC vacant capsules. This allows you to directly reference our active Type IV Drug Master File (DMF #31186) in your regulatory filings, significantly accelerating the approval process for your formulation in the U.S. market.

Absolutely. Our facility is not only U.S. FDA Registered but also maintains a complete audit trail under ISO 9001:2015. We welcome quality assurance teams to review our Batch Production Records (BPR) and validation protocols for gelatin and enteric hollow capsules.

We use temperature-controlled packaging and specialized moisture-barrier liners for all international exports. For HPMC shells, which have naturally lower moisture content ($4\%-6\%$), they offer superior stability compared to gelatin when shipping to regions with high humidity or fluctuating temperatures.

We offer flexible supply chain solutions for both pharmaceutical B2B and cross-border e-commerce models. Our warehouse maintains a steady stock of standard sizes (Size 00, 0, 1) in clear and white, ready for immediate global dispatch.